Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 427-430-5
CAS number: 54301-26-7
Summarizing read-across to undecylenoyl glycine, it is possible to predict the toxicity profile of target substance based on the source substances capryloyl glycine and undecylenic acid (See document "Prediction of reproductive toxicity for undecylenoyl glycine using read-across approach").
A well conducted study OECD test n°422 is available on Capryloyl glycine (source substance) and gave a NOAEL for parental toxicity of 200 mg/kg/day, a NOEL for reproductive performance (mating and fertility) of 200 mg/kg/day and NOEL for toxic effects on progeny of 200 mg/kg/day (highest dose tested).
Furthermore, a Reproduction/ Developmental Toxicity Screening Test (OECD 421) is available on the source substance undecylenic acid and was also considered robust scientifically. Under the experimental conditions of this study, NOAEL value for parental toxicity was considered to be 150 mg/kg/day, NOEL for reproductive performance (mating and fertility) was considered to be 450 mg/kg/day. There was no substance induced effect on male and female reproductive performance, or on the progeny at any dose level.
Moreover, the administration of undecylenoyl glycine by oral route during 28 days in rats did not show any effect on the sexual organs.
Toxicity to reproduction of target substance undecylenoyl glycine based on read-across can be predicted as follows: - NOAEL for parental toxicity = 150 mg/kg- NOAEL for reproductive performance = 200 mg/kg
In accordance with EC Regulation No. 1907/2006, Annex XI, 1.5 to REACH
regulations ‘Read-across and grouping of substance’. Toxicity to
reproduction was evaluated for the target substance undecylenoyl glycine
(CAS No. 54301-26-7), considering capryloyl glycine (CAS No. 14246-53-8)
and undecylenic acid (CAS No. 112-38-9) as source substances. Read
across was performed as per scenario 1 of read-across assessment
framework (RAAF) based on the hypothesis that different substances give
rise to similar or common compounds to which the organism is exposed.
The amino acid alkyl amides are reported to be synthesized by acylation
of amino acids with fatty acids or fatty acid chlorides. Compounds of
this class share common metabolic pathways where parent molecule get
metabolized to amino acid and fatty acid by the action of enzyme
amidase. Rationale using Scenario 1 for read-across hypothesis is based
on common and shared properties between source and target molecule as:
i. Structurally similar compounds with common mechanism of action
linking the possibility of similar qualitative and quantitative effects.
ii. Exposure to other compounds by bio-transformation of parent molecule
to similar metabolites i.e. formation of common and non-common compound
Bio-transformation of source and target substance will lead to
generation of glycine as common metabolite while caprylic acid and
undecylenic acid will be produced as non-common compounds by capryloyl
glycine and undecylenoyl glycine, respectively. This conclusion
justifies the use of analogue approach scenario 1 to gather necessary
information required for data gap filling using capryloyl glycine as the
Structural similarity and differences between source and target
substances, toxicity of glycine (common compound) and the consequences
of the formation of non common compounds were discussed in the document
"Prediction of reproductive toxicity for undecylenoyl glycine using
read-across approach" (see attached justification). Furthermore,
toxicity to reproduction data of undecylenic acid was taken into account
to reinforce the prediction.
- NOAEL for parental toxicity = 150 mg/kg
- NOAEL for reproductive performance = 200 mg/kg
Based on data available on the source substances and findings of the subacute toxicity study (OECD 407) available with the target sustance, it can be concluded that undecylenoyl glycine does not affect reproductive performance and fertility and is not classified according to the GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again